Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01532856
Status:
UNKNOWN
Last Update Posted:
2012-02-15
First Post:
2012-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iberoamerican Protocol With Thalidomide in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65 Years
Sponsor:
Grupo de Estudos Multicentricos em Onco-Hematologia
Organization:
Study Overview
Official Title:
Iberoamerican Phase III International Study, Open, Multicenter, Randomized, Comparative of Thalidomide / Cyclophosphamide / Dexamethasone Versus Thalidomide / Dexamethasone Versus Thalidomide / Melphalan / Prednisone as Induction Therapy Followed by Maintenance Therapy With Thalidomide + Prednisone Versus Thalidomide Alone in Patients With Symptomatic Newly Diagnosed Multiple Myeloma Over 65years.
Status:
UNKNOWN
Status Verified Date:
2012-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol is an international, multicenter, comparative, open and randomized study designed to compare the safety and efficacy (in terms of response rate) from three induction chemotherapy schemes -Thalidomide/Cyclophosphamide/Dexamethasone versus Thalidomide/Dexamethasone versus Thalidomide/Melphalan/Prednisone. Finally, this study is also designed to compare the safety and efficacy (in terms of duration of response) of two maintenance chemotherapy regimens - Thalidomide/Prednisone versus Thalidomide. Each treatment arm will include 100 patients and assessments and scheduled visits will be conducted in three periods: Pre-treatment, treatment and monitoring. Security will be evaluated by monitoring all adverse events, physical examination, vital signs and biochemical studies. Response to treatment will be evaluated according to the EBMT21 criteria and will be assessed on day 1 of each cycle of induction, at the end of nine cycles of induction therapy and monthly during the first year of maintenance therapy and every 3 months thereafter.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: